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Financement de l’UE (5 555 836 €) : Thérapie régénérative du disque intervertébral : un essai de phase 2b en double aveugle d’injection intradiscale de cellules stromales mésenchymateuses dans la … Hor15/12/2016 Programme de recherche et d'innovation de l'UE « Horizon »
Vue d’ensemble
Texte
Thérapie régénérative du disque intervertébral : un essai de phase 2b en double aveugle d’injection intradiscale de cellules stromales mésenchymateuses dans la discopathie dégénérative de la discopathie lombaire ne répondant pas au traitement conventionnel
The World Health Organisation (WHO) has included low back pain in its list of twelve priority diseases. Notably, Degenerative disc disease (DDD) presents a large, unmet medical need which results in a disabling loss of mechanical function. Today, no efficient therapy is available. Chronic cases often receive surgery, which may lead to biomechanical problems and accelerated degeneration of adjacent segments. Our consortium partners have developed and studied stem cell-based, regenerative therapies with encouraging results in phase 1 and 2a trials. Patients exhibited rapid and progressive improvement of functional and pain indexes by 50% within 6 months and by 65% to 78% after 1 year with no side effects. In addition, MRI T2 relaxation measurements demonstrated a significant improvement. To develop the world’s first rigorously proven, effective treatment of DDD, RESPINE aims to assess, via a multicentre, randomized, controlled, phase 2b clinical trial including 112 patients with DDD, the efficacy of an allogenic intervertebral mesenchymal stem cell (MSC)-based therapy. This innovative therapy aims to rapidly (within 3 months) and sustainably (at least 24 months) reduce pain and disability. In addition, the consortium aims to provide new knowledge on immune response & safety associated with allogeneic BM-MSC intradiscal injection. This simple procedure would be cost-effective, minimally invasive, and standardised. The transfer to the clinic will be prepared at a cost below 10k€ thanks to the strategy of production of allogenic cells, automation & EU standardisation. At the end of the RESPINE trial, we aim to propose a broadly available and clinically applicable treatment for DDD, marketed by European SMEs.
| Assistance Publique Hopitaux de Paris | 375 313 € |
| BG KLINIKUM BERGMANNSTROST HALLE gGmbH | 199 016 € |
| Centre Hospitalier Universitaire de Nantes | 307 853 € |
| Centre Hospitalier Universitaire de Rennes | 95 679 € |
| Centre Hospitalier Universitaire Montpellier | 933 544 € |
| Centre National de la Recherche Scientifique CNRS | 220 306 € |
| Citospin SL | 964 127 € |
| Ecrin European Clinical Research Infrastructure Network | 207 825 € |
| Fondazione Policlinico Universitario Campus BIO Medico | 87 134 € |
| HEINRICH-HEINE-UNIVERSITAET DUESSELDORF | 0,00 € |
| Human Cell Design | 233 717 € |
| Institut de Terapia Regenerativa Tisular SL | 386 673 € |
| Institut National de la Sante et de la Recherche Medicale | 0,00 € |
| Universidad de Navarra | 351 750 € |
| Universidad de Valladolid | 420 538 € |
| Universita Campus BIO Medico Di Roma | 264 116 € |
| Universite de Montpellier | 249 500 € |
| Universite Paul Sabatier Toulouse III | 0,00 € |
| University of Galway | 258 746 € |
https://cordis.europa.eu/project/id/732163
Cette annonce se réfère à une date antérieure et ne reflète pas nécessairement l’état actuel.
